FDA approves new buprenorphine treatment option for opioid use disorder

Thursday, May 25, 2023

The US Food and Drug Administration (FDA) has approved subcutaneous injection (for use below the skin) of extended-release Brixadi (buprenorphine) to treat moderate to severe opioid use disorder (OUD). Brixadi is available in two formulations, a weekly injection that can be used in patients who have started treatment with a single dose of a buprenorphine-containing product administered transmucosally or are already being treated with buprenorphine, and a monthly version for patients who are already taking buprenorphine. being treated with buprenorphine.

"Buprenorphine is an important treatment option for opioid use disorder. Today's approval expands dosing options and gives people with opioid use disorder a greater opportunity to maintain a lasting recovery," said the commissioner. of the FDA, Dr. Robert M. Califf . "FDA will continue to take important steps necessary to undertake efforts to advance evidence-based treatments for substance use disorders, which is a strategic priority under the FDA's Overdose Prevention  Framework . "

Buprenorphine is a safe and effective medication for the treatment of opioid use disorder. According to the Substance Abuse and Mental Health Administration (SAMHSA), patients receiving medications for opioid use disorder cut their risk of death from all causes in half.

The FDA continues to implement a comprehensive approach to increase options for treating opioid use disorder. Earlier this month, the agency issued a joint letter with SAMHSA to clarify the importance of counseling and other services as part of a comprehensive treatment plan for opioid use disorder and also to reiterate that the provision of buprenorphine is not must be contingent on participation in such services. The agency also held a virtual public workshop that highlighted the need for additional strengths and dosing regimens for extended-release formulations. 

Brixadi is approved as weekly and monthly subcutaneous injectable formulations in variable doses, including lower doses that may be appropriate for those who cannot tolerate the higher doses of extended-release buprenorphine that are currently available. The weekly doses are 8 milligrams (mg), 16 mg, 24 mg, 32 mg; and the monthly doses are 64 mg, 96 mg, 128 mg. The approved weekly formulation at several lower concentrations offers a new option for recovering individuals who may benefit from a weekly injection to maintain treatment adherence. Brixadi will be available through a Risk Evaluation and Mitigation Strategy (REMS) program and will be administered only by healthcare providers in a healthcare setting.

The most common adverse reactions (occurring in ≥5% of patients) with Brixadi include injection site pain, headache, constipation, nausea, injection site erythema, skin itching at the injection site. injection (injection site pruritus), insomnia and urinary tract infections. 

The safety and efficacy of Brixadi were evaluated in a behavioral pharmacology study evaluating the ability of twice weekly doses of Brixadi to block the subjective effects of opioids and in a randomized, double-blind, active-controlled clinical study in 428 adults diagnosed with moderate to severe opioid use disorder. After an initial test dose of buprenorphine administered transmucosally, patients were randomized to treatment with Brixadi plus sublingual placebo or active sublingual buprenorphine plus placebo injections. After the first week titration, patients were treated with weekly injections for 12 weeks and then switched to monthly injections for an additional 12 weeks. Response to treatment was measured by urine drug detection and self-reported use of illicit opioids during the treatment period. Patients were considered to have responded if they had negative opioid assessments at the end of each of the two treatment phases. The proportion of patients who met the definition of a responder was 16.9% in the Brixadi group and 14.0% in the sublingual buprenorphine group. 

The FDA granted Brixadi approval to Braeburn Inc.

The agency remains focused on responding to all facets of substance use, misuse, substance use disorders, overdoses, and death in the United States through the FDA's Overdose Prevention Framework . The framework's priorities include: supporting primary prevention by eliminating unnecessary initial exposure to prescription drugs and inappropriate prolonged prescription; promote harm reduction through innovation and education; advance the development of evidence-based treatments for substance use disorders; and protect the public from unapproved, diverted, or counterfeit drugs that pose risks of overdose.



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